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Amatem Soft Gel Forte

Elbe Pharma Nig. Ltd
1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Email: elbepharma@gmail.com
Tel: 01-773-1473, 01-8179648, 08033160649
Fax: 01-452-8219

Brand Name

Amatem Soft Gel Forte

Manufacturer

Olive Healthcare
197/2, Athliyawad, Dabhel Village, DAMAN- 396 210 (U.T), India
URL: www.olivehealthcare.co.in

Therapeutic Class

Antimalarial drugs

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: B4-0952): Each Soft Gelatin Capsule contains Artemether Ph. Int. 80 mg; Lumefantrine Ph. Int. 480 mg; Excipients q.s. Approved colour used in capsules shell.

Pack Size: Blister packs of 1 x 6 soft gelatin capsules.

Amatem Soft Gel Forte

Pharmacology

CLINICAL PHARMACOLOGY
Mechanism of Action:

Artemether and Lumefantrine combination is a fixed dose artemisinin-based combination therapy (ACT) combining artemether, an artemisinin derivative and lumefantrine, a synthetic antimalarial drug.

Pharmacokinetics:

Artemether is absorbed with peak plasma concentrations reached about 2 hours after dosing. Absorption of lumefantrine, a highly lipophilic compound, starts after a lag-time of up to 2 hours, with peak plasma concentrations about 6 to 8 hours after administration.

Artemether and lumefantrine are both highly bound to human serum proteins in vitro (95.4% and 99.7% respectively). Artemether are cleared from plasma with elimination half-life of about 2 hours. Lumefantrine is eliminated more slowly, with a terminal half-life of 3-6 days. 

No specific pharmacokinetic studies have been performed in patients older than 65 years of age.

Indications

For the treatment of most forms and resistant types of malaria.

Contra-indications

• Patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine).
• Patients with disturbances of electrolyte balance e.g. hypokalemia.

Precautions/Warnings

• It must not be used in first Trimester of Pregnancy.

• It has not been evaluated for treatment of severe malaria

• For the treatment of most forms and resistant types of malaria.

Interactions

It has the interactions with other antimalarials, CYP450 3M Inhibitors, Protease Inhibitor and anti-retroviral Drugs.

PREGNANCY AND LACTATION

Pregnancy

There is insufficient data from the use of Arterhether and lumefantrine in pregnant women. Based on animal data, it is suspected to cause serious birth defects when administered during the first trimester of pregnancy.

During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus.

Lactation

Animal data suggest excretion into breast milk but no data are available in humans. Women taking the product should not breast-feed during their treatment.

Due to the long elimination half-life of lumefantrine (4 to 6 days), it is recommended that breastfeeding should not resume until at least one week after the last dose unless potential benefits to the mother and child outweigh-the risk of treatment.

Adverse Effects

Dosage & Administration

Dosage in Adult Patients (>16 years of age) 
A 3-day treatment schedule with a total of 6 doses is recommended for adult patients with a bodyweight of 35 kg and above: 
One capsule as an initial dose, 1 capsule again after 8 hours and then 1 capsule twice daily (morning and evening) for the following two days (total course of 6 capsules).

D0 NOT EXCEED THE DOSAGE PRESCRIBED

Weight in Kgs. Total Capsules Dosage Regimen
35 kg - above 6 Day-1 Day-2 Day-3
0 Hours
(Initial dose)
8 Hours
(after 1st dose)
24
Hours
36
Hours
48
Hours
60
Hours
1 Capsule 1 Capsule 1 Capsule 1 Capsule 1 Capsule 1 Capsule

OVERDOSE

In case of suspected Overdosage symptomatic and supportive Therapy should be given as appropriate which including ECG and blood potassium monitoring.

Storage/Handling Recommendations

Store below 25oC in cool & dry place.

Review Date

2017-05-11 03:27:03